FDA grants approval to Obizur

SILVER SPRING, Md. — The Food and Drug Administration last week announced approval for Obizur [antihemophilic factor (recombinant), porcine sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A. 

 

The disorder is rare and potentially life threatening. It's caused by the development of antibodies directed against the body's own FVIII, which is a protein important for blood clotting. When a person's blood doesn't clot like it normally should, excessive bleeding can spontaneously occur or will happen after an injury or a surgical procedure. 

 

“The approval of this product provides an important therapeutic option for use in the care of patients with this rare disease,” said Karen Midthun, MD, director of FDA’s Center for Biologics Evaluation and Research.

 

Obizur is classified as an orphan drug by the FDA because of its use to treat a rare disease or condition. The drug is manufactured by Baxter Healthcare Corp.